Satralizumab in Patients with Neuromyelitis Optica Spectrum Disorder and Concomitant Autoimmune Disease (4118)

Objective: To evaluate the safety and efficacy of satralizumab in neuromyelitis optica spectrum disorder (NMOSD) patients with concomitant autoimmune diseases (CAIDs) from the SAkura studies. Background: NMOSD is frequently associated with one or more CAIDs. The SAkura studies (SAkuraSky and SAkuraStar) enrolled a diverse patient population reflective of real-world practice, including patients with CAIDs. In SAkuraSky (satralizumab in combination with baseline immunosuppressants; NCT02028884) and SAkuraStar (satralizumab monotherapy; NCT02073279), satralizumab showed a reduced risk of relapse versus placebo and had a favorable safety profile. Design/Methods: This analysis was performed using pooled data from patients with a medical history of CAIDs in the intention-to-treat population of the SAkura studies. The frequency of protocol-defined relapses (PDRs) in each treatment arm was reported. Safety was evaluated in the pooled safety analysis population throughout the double-blind period using adverse event (AE) rates per 100 patient-years (PY). Results: 31 patients with CAIDs were enrolled in the SAkura studies (15 in SAkuraSky and 16 in SAkuraStar); of these patients, 15 received satralizumab and 16 received placebo. The most commonly reported CAIDs were Sjogren’s syndrome (n=9) and systemic lupus erythematosus (n=7). In this CAID cohort, the rate of AEs was comparable with satralizumab versus placebo (707.98 vs 795.88 events/100PY, respectively). The rate of serious AEs was 43.83 events/100PY with satralizumab and 33.16 events/100PY with placebo; the difference between arms was mainly driven by multiple events reported in one patient in SAkuraStar. The rate of infections was 175.31 events/100PY with satralizumab versus 232.13 events/100PY with placebo. The most common AEs in both treatment groups were urinary tract infection and upper respiratory tract infection. Consistent with the primary efficacy analysis, fewer patients experienced a PDR with satralizumab versus placebo (3 [20%] vs 7 [44%]). Conclusions: Satralizumab was well tolerated in NMOSD patients with CAIDs, with comparable safety and efficacy to the overall SAkura study populations. Disclosure: Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi Genzyme. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Yeaman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. The institution of Dr. Yeaman has received research support from National Institutes of Health. The institution of Dr. Yeaman has received research support from U.S. Department of Defense. Dr. Yeaman has received intellectual property interests from a discovery or technology relating to health care. Dr. Yeaman has received intellectual property interests from a discovery or technology relating to health care. Dr. Weinshenker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Weinshenker has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Weinshenker has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Viela Bio. Dr. Weinshenker has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche Group (Chugai, Genentech, Roche). The institution of Dr. Weinshenker has received research support from Guthy Jackson Charitable Foundation. Dr. Weinshenker has received intellectual property interests from a discovery or technology relating to health care. Dr. Weinshenker has received personal compensation in the range of $500-$4,999 for serving as a speaker at internal meeting with Genentech. Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck, Mitsubushi, UCB, Roche, Amplo, Alexion, Vitaccess, Argenx. Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis, Roche, Argenx, Alexion. Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Merck, Roche, Viela Bio, Alexion. The institution of Dr. Palace has received research support from Merck, MedImmune, MS Society, AMPLO. Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. Xiujing Kou has nothing to disclose. Daniela Stokmaier has received personal compensation for serving as an employee of Roche. Kristina Weber has received personal compensation for serving as an employee of F. Hoffmann-La Roche AG. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Tanabe-Mitsubishi. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Chigai. Dr. Fujihara has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for EMC. The institution of Dr. Fujihara has received research support from Ministry of Education, Science and Technology of Japan. The institution of Dr. Fujihara has received research support from Ministry of Health, Welfare and Labor of Japan. Dr. Fujihara has received personal compensation in the range of $10,000-$49,999 for serving as a speaker, chair, etc with Novartis. Dr. Fujihara has received personal compensation in the range of $5,000-$9,999 for serving as a speaker, chair, etc with Biogen. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a speaker, chair, etc with Tanabe-Mitsubishi. Dr. Fujihara has received personal compensation in the range of $5,000-$9,999 for serving as a apeaker, chair, etc with Chugai. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a speaker, chair, etc with Alexion. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a chair with Asahi Kasei Medical. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a speaker with Eisai. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a speaker, chair with Teijin. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a speaker with Bayer. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a speaker with Roche. Dr. Yamamura has nothing to disclose.